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临床试验/NCT07250191
NCT07250191已完成不适用

The Acute Effects of Energy and Carbohydrate Restriction on Postprandial Metabolism

University of Bath1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Glucose Concentration

研究概览

简要总结

Most individuals spend the majority of the day in a fed state, making postprandial blood glucose and lipid regulation a central component of metabolic health. Short periods of fasting or reduced carbohydrate intake can occur frequently in daily life, whether through intentional dietary practices (e.g. intermittent fasting), cultural or religious traditions, or unstructured eating patterns. These periods can induce measurable metabolic changes, but the acute effects of a single 24-hour period of fasting or carbohydrate restriction on postprandial metabolism upon refeeding remain poorly characterised.

This study will examine how 24 hours of either complete fasting or low carbohydrate intake without energy restriction influence postprandial blood glucose and lipid concentrations, as well as related metabolic markers, in healthy adults, in comparison to a habitual high carbohydrate control diet. Participants will complete all three conditions in a randomised order, consuming a standardised meal test after each 24-hour condition. Repeated blood sampling and gas exchange measurements will be carried out to assess postprandial metabolic responses.

The aim of this study is to characterise whether acute periods of fasting and low carbohydrate restriction elicit distinct or comparable alterations in postprandial metabolic responses. A clearer understanding of these acute physiological effects can help inform how variations in eating patterns influence glucose and lipid handling in individuals without metabolic disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged between 18-40 years
  • •Have a BMI of 18.5-29.9 kg/m2

排除标准

  • •Diagnosed with any major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
  • •Use of medication that may interfere with study outcomes (e.g. glucose or lipid-lowering medications)
  • •Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
  • •Has a habitually low carbohydrate intake (<150g carbohydrates/day)
  • •Current or previous eating disorder
  • •Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
  • •Insufficient mental capacity or language skills to independently understand and follow the study protocol
  • •Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)
  • •Any other condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment

研究组 & 干预措施

Habital control diet

No Intervention

100% of energy requirements, ≥150 carbohydrate/day

Fasting

Experimental

No energy intake

干预措施: Fasting (Behavioral)

Carbohydrate Restriction

Experimental

100% of energy requirements, ≤20g carbohydrate

干预措施: Carbohydrate restriction (Behavioral)

结局指标

主要结局

Glucose Concentration

时间窗: After each 24-hour dietary condition

Plasma glucose concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test

Triglyceride Concentration

时间窗: After each 24-hour dietary condition

Plasma triglyceride concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test

次要结局

  • Insulin Concentration(After each 24-hour dietary condition)
  • Non-esterified Fatty Acid Concentration(After each 24-hour dietary condition)
  • Beta-hydroxybutyrate Concentration(After each 24-hour dietary condition)
  • Substrate Oxidation(After each 24-hour dietary condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guoda Karoblyte

Doctoral Researcher

University of Bath

研究点 (1)

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